145. Brazil had suggested at the TRIPS Council meeting on 30 January "that the next session of the TRIPS Council includes a presentation by the Secretariat on the notification system currently in place", as part of the suggested activities to raise awareness and address lack of knowledge, especially in procurement agencies. To address this proposal, the Secretariat has prepared a brief presentation on notifications that are required in order to use the Paragraph 6 System3. We have also made available hard copies of the Guide to Notifications which is based on the material that can be accessed on the WTO's dedicated webpage. To further simplify the submission of notifications, Members seeking to notify under the System can soon also opt to use the eTRIPS online submission webtool once it is finalized and operational.
146. The purpose of this presentation is to familiarize delegations with that material, including model forms for each of the three notifications that can be downloaded from the webpage. Obviously, the material has been prepared by the Secretariat on its own responsibility in order to assist Members who are considering using the System. The clear link with capacity building also explains the coverage under the item on technical cooperation activities at this meeting of the TRIPS Council.
147. We also wanted to introduce the webpage, because it is often very easy to say that 'all of this is available on our webpage'. We thought that, in order to introduce the item, we briefly run you through what is available on our webpage dedicated to issues related to TRIPS and public health.
148. As you see the gateway page on TRIPS and public health provides a brief general overview of matters related to TRIPS and public health, but currently focuses on the implementation and use of the Paragraph 6 System. The Secretariat is working on expanding the webpage to cover other relevant issues at the crossroad between IPRs and public health.
149. The first entry in the notifications box links to a webpage that recalls the context and legal basis for notifications by both importing and exporting Members and outlines the key elements of such notifications. In order to respond to the requirement on the WTO Secretariat to make available publicly the notifications by the importing and exporting Members (fn. 5 and 9 of the Annex to the amended TRIPS Agreement), this webpage also provides direct access to these notifications. By way of illustration, reference is made to the page addressing specifically importing Members and the link to documents online where specific notifications can be accessed.
150. On Slide 5 we have a second entry in the notifications box that links to the Guide to Notifications. This Guide is available online. A print out version of the Guide has also been made available for delegations in the back of the room.
151. Slide 6 on "How to notify" outlines formal requirements to submit a notification to the WTO. It briefly addresses the question of who signs the notification, i.e. any authorized government official. It also clarifies that there is no need to get approval by any WTO body, which is a common misunderstanding when I present on these issues, and that notifications are to be sent to the TRIPS Council through the Secretariat. In addition to communication by e-mail, fax and post, in the future we will also add the e-TRIPS online tool which we will soon make available.
152. These notifications are circulated in document series IP/N/8/.. (importing Member's intention to use), IP/N/9/.. (importing Member's specific needs) and IP/N/10/.. (exporting Member's grant of compulsory licence and conditions attached to it) and are available on our documents online webpage.
153. Slide 7 on "What to notify" lists three types of notifications required under the System. The first is by the importing Member or Members, that is the general notification of the intention to use the System. Least developed countries do not have to notify this intention. The second notification by the importing Member is about its specific needs – what are the pharmaceuticals that are needed and how much of these medicines are needed, we will get back to this when we get to the model form. And the third is by the exporting Member that has to notify the grant of the compulsory licence and the conditions attached to it.
154. In order to simplify the task of those who envisage to use this System, we have made available already for some time, model notifications for these types of notifications (Slide 8). We are operating at this stage on a dual legal basis, i.e. those that have accepted the TRIPS Amendment and that are therefore operating on the basis of Article 31bis of the amended TRIPS Agreement and the Annex and the Appendix to the Annex; and those that are yet to accept the TRIPS Amendment and that continue to operate on the basis of the 2003 waiver Decision.
155. This why we have now two sets of model notifications online which are otherwise in substance identical except for the legal basis, depending whether you operate on the basis of Article 31bis of course the legal basis would be different from those operating on the basis of the waiver Decision.
156. For illustrative purposes, the rest of this presentation will only refer to notifications that are made pursuant to Article 31bis of the amended TRIPS Agreement, it being understood that the same explanations would equally apply to notifications made under the 2003 waiver Decision.
157. Slide 9 on "First notification of importing Member's intention to use the System" summarizes the requirements for this notification. As you can see from the model notification, what is actually required is one sentence that signals a Member's intention to use the System. There is some optional language I will come to, but nothing more that needs to be notified as part of this first notification.
158. Least developed countries do not need to make this notification, and developed countries are, by definition, excluded from making this notification, because they have committed not to use this System as importers.
159. When to make the notification? It can be made at any time, either together with the details regarding the needed medicines (see second notification) or prior to such notification. There is no given time when this notification has to be made, it has to be notified once only, so once you have used the System for the first time there is no need to notify again the intention to use it.
160. It is important to note that the notification does not commit a Member to the actual use of the System. Making this notification does not mean that you have to follow up and also submit a specific notification about your needs in the pharmaceutical sector.
161. What needs to be notified? The optional language goes back to a provision in Para.1(b) of the Annex to the amended TRIPS Agreement which says that "a Member may notify at any time that it will use the System in whole or in a limited way, for example in the case of a national emergency or other circumstances of extreme urgency or in cases of public non-commercial use".
162. For Members who wish to make use of the System in such a limited way, we have suggested this optional language to provide assistance in case needed. I should also note that the Chairman's statement read out before the adoption of the Protocol in December 2005 noted several Members' confirmation to use the System only in circumstances of extreme urgency.
163. Here, a question for consideration: why has no such notification been made to date? That is a question to be asked when it comes to the functioning of the System.
164. Slide 10 deals with the second notification of the importing Member's specific needs (products, other details). Here again I would like to underline that the model forum for this notification can be downloaded from our webpages and is easily filled in, provided the importing Member is in a position to identify (i) exactly what and how much is needed to treat patients and (ii) any existing patents for the needed medicines. If these prerequisites are given, it should be easy to fill in the notification.
165. Why is there a need to make this notification? From our perspective, this notification has an important and so far largely underutilized signalling function by which other Members and the public are informed about the concrete needs of an importing Member. As such, it can thus be used as a practical procurement tool to trigger the interest of potential suppliers, almost equivalent to a call for tenders. There is ultimately no obligation to procure the medicines under the System if other sources of supply can later be identified that can, for example, produce the products off patent or at an affordable price. This could reinforce consideration of the mere use of this notification as a procurement tool to flag a country's needs.
166. Who is obliged to make this notification? Notifications must be made by developing countries and LDCs that wish to import products under the System; it can be made by a regional organization on behalf of and with the consent of RTA members under the RTA mechanism (see fn 4 to the Annex of the TRIPS Agreement). Also, nothing prevents other Members from making joint notifications. This is supporting the objective of harnessing economies of scale and makes production under the System economically more viable for generic companies. Note that no (further) notification is required in case of imports from another RTA Member that is either manufacturing the needed products or imports them from third country suppliers.
167. What needs to be notified? The names and expected quantities of the needed medicines; but not, for example, the name of the potential supplier. It is actually preferable for a government not to do so, as this could limit potential competition among generic companies regarding the prices that could be offered for the needed medicines. So, it is important to note that there is no need to notify the name of the supplier, nor any time-frame for the supply and use of the imported medicines. None of this is mandatory for the importing country that notifies its needs.
168. Next, a Member that wishes to import medicines needs to notify that it has established that there are insufficient or no manufacturing capacities in its territory (see Appendix to the Annex), and how this has been established (see Chairman's statement read out prior to the adoption of the Protocol). This does not apply to least developed countries which are automatically assumed as not having sufficient manufacturing capacities.
169. The model notification also suggests some optional language. If there is no patent in force in the importing country, there is no obligation to notify anything in this regard. However, the very absence of patents in the importing country may be a useful piece of information for those who are intending to use the System, and hence the suggestion of optional language to also include this information in the notification.
170. Otherwise what needs to be notified when there are patents in force is the grant or the intention to grant a compulsory licence. In the case of least developed countries, as the example of Rwanda had shown in the past, it is also sufficient to refer to the extended transition period in the pharmaceutical sector instead of mentioning any grant or intention of granting compulsory licences.
171. Again, this notification raises a question for consideration to which we are yet to receive an answer. Why are such notifications not used more regularly by Members to flag their needs and thus to prepare the grounds for the actual procurement of the needed medicines, knowing that there is no obligation to run through the System to its end if you find different sources of supply.
172. The third and last notification concerns the exporting Member's compulsory licence and conditions attached to it. Again this should be easy to fill in for the exporting country. The Survey of WTO Members' implementing legislation which the Chair has mentioned in his introduction shows that legislation which has been put in place by WTO Members so far addresses these conditions in a flexible manner, such as the quantities covered by the compulsory licences and its duration. This includes, for example in some implementing laws, the possibility to augment authorized quantities through a simplified and accelerated procedure, or to renew the initial period of the compulsory licence or to review the duration by means of a simplified procedure.
173. Why is this notification needed? It is basically the response to the second notification by the importing country, so it is triggered by that importing country's notification of specific needs. Who is going to make this notification? Any exporting Member, for every compulsory licence that is used exclusively for production and export of medicines to an eligible importing Member.
174. Please note that there is no such notification required again in the context of regional trade agreements, so where that qualifies under the RTA mechanism, in case of exports from an RTA Member to other RTA Members under the regional mechanism. Also, there is no notification required when we operate under standard compulsory licence, in other words, when the predominant part of the production is used for the supply of the domestic market of the country that is also the host of the manufacturing company.
175. When to notify this third notification? Prior to the export, that is important, otherwise there is no specific rule in here.
176. What to notify? This is addressed by the set of bullet points in the model form which are required pursuant to Para.2(c) of the Annex to the TRIPS Agreement. Provided that these details are covered by the compulsory licence, this requirement could also be met by attaching a copy of the compulsory licence to the cover letter.
177. Other information, such as the number of the patent(s) covered by the compulsory licences, can be included on an optional basis. This would help to clarify the exact scope of the compulsory licences granted by the exporting country.
178. Finally, there is also a need to notify a link to the webpage where the licensee posts information regarding the quantities supplied to each destination under the System and the distinguishing features applied to the products. This can either be a webpage set up by the licensee (see the example of Apotex, which exported under compulsory licence from Canada to Rwanda) or a dedicated page on the WTO website (see fn.7 to the Annex).
179. The next slide is a summary of the resources which are available on the WTO webpage. On the final slide, and this is not related to notifications, I would like to give you the link to the document the Chair mentioned before, i.e. the Survey of WTO Members' implementing legislation, which is available online as well. Almost exclusively in table format, it provides an overview of how the key features of this System have been implemented in domestic law.